Yield is one of the process performance indicators for production of biopharmaceuticals that is typically monitored and optimized to improve productivity. Maximizing overall process yield remains an important goal into the commercial production phase of a product’s lifecycle in order to reduce cost of goods and enhance supply robustness. Variability in the overall downstream yield was observed through process monitoring for a monoclonal antibody manufacturing process. A technical evaluation was initiated to improve process understanding and to identify potential yield improvements. Statistical methods, including multivariate data analyses, were used to identify sources of yield variability. From the analysis, two process steps were identified as major contributors to overall yield variability. Potential for yield improvement in one of the steps (anion exchange chromatography polishing) was evaluated, leveraging knowledge from process characterization studies and confirmation through small-scale studies. Based on the study results, potential overall downstream increase up to 6% can be realized with no meaningful impact to product quality. This evaluation improved understanding of manufacturing process variability and provides opportunities for continuous improvement in a post-approval environment.

Technical Evaluation to understand overall yield variability in a mAb manufacturing process and potential opportunities for yield improvement

2019 Spring National Meeting

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